UCB, a global biopharmaceutical company, announced the submission of an application for an Import Drug License to the Chinese Food and Drug Administration (CFDA) for the approval of CIMZIA® (certolizumab pegol) to treat moderate-to-severe rheumatoid arthritis (RA).
Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical needs and commercial potential, announced that its exclusive North American licensee for bremelanotide, AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG), has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for bremelanotide for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. If approved, bremelanotide would become the first and only as desired pharmacologic option in the U.S. indicated for the treatment of HSDD in premenopausal women.
The European Medicines Agency (EMA) has accepted for review Sanofi’s regulatory submission for sotagliflozin. If approved, the oral treatment would be used as an addition to insulin therapy to improve blood sugar control in adults with type 1 diabetes mellitus.
Shire plc (LSE: SHP, NASDAQ: SHPG) announced today the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for lanadelumab (SHP643) and also reports that Health Canada has completed screening and accepted the New Drug Submission (NDS) under Priority Review for this investigational compound.
Medtronic has finally received FDA clearance for Guardian Connect, its smartphone-connected standalone CGM for patients who use multiple daily injections (MDI) for their insulin. Medtronic's closed-loop system for pump users was cleared in 2016.
Global pharmaceutical company Mylan N.V. (MYL) today announced that it will introduce in the U.S. a third cost-saving HIV combination. The U.S. Food and Drug Administration (FDA) approved Symfi™ (efavirenz, lamivudine and tenofovir disoproxil fumarate) 600 mg/300 mg/300 mg tablets, a once-daily, single-tablet regimen (STR), indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg.
Novartis announced today that the US Food and Drug Administration (FDA) expanded the indication for Tasigna® (nilotinib) to include treatment of first- and second-line pediatric patients one year of age or older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP).
Bristol-Myers Squibb Company (BMY) announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for priority review of Opdivo (nivolumab) plus Yervoy (ipilimumab) to treat intermediate- and poor-risk patients with advanced renal cell carcinoma (RCC). The FDA also previously granted Breakthrough Therapy Designation for this application, which is the 2nd indication for which the Opdivo plus Yervoy combination has received this designation.
Medical device maker DexCom announced Tuesday that the company has received a de novo clearance from the FDA to sell its latest continuous glucose monitoring system — the G6 — that requires no fingerstick calibration.
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